Principal Stat Programmer

Job Summary:

• Serve as a technical subject matter expert (SME) for CDISC and other industry and regulatory standards.
• Contribute to the development of standardized programming tools, macros, and SOPs for efficiency and compliance.
• Lead multiple complex and/or global clinical trial programming projects, mentoring and guiding statistical programming teams.
• Ensure compliance of programming deliverables with CDISC standards, regulatory requirements, and internal guidelines.

Key Responsibilities:

• Collaborate with biostatistics and programming teams to establish SOPs, guidelines, policies, and procedures.
• Develop and optimize programming tools and macros for standardization and efficiency.
• Serve as an SME on CDISC standards:
• Provide guidance and training to Biostatistics and other departments on CDISC usage.
• Conduct compliance reviews of project deliverables (SDTM, ADaM, DEFINE.XML, and other regulatory documents).
• Participate in industry standards organizations and provide updates to the Biometrics department.
• Transfer deliverables and coordinate with cross-functional teams for project execution.
• Mentor junior programmers and support their understanding of CDISC standards and clinical trial processes.
• Perform other work-related duties and minimal travel as required.

Qualifications:

• Undergraduate degree in a scientific or statistical discipline (or equivalent combination of education and experience).
• Extensive SAS or equivalent programming experience in clinical trial environments.
• Knowledge and hands-on experience with CDISC standards (SDTM, ADaM, DEFINE.XML).
• Regulatory submission experience preferred.
• Proven experience leading multiple complex or global projects.
• Experience mentoring others in clinical trial processes and CDISC standards.
• Excellent written and verbal communication skills; proficiency in English.

Skills Required:

• SAS programming and clinical data analysis
• CDISC Standards (SDTM, ADaM, DEFINE.XML)
• Clinical trial data management and regulatory compliance
• SOP development and process standardization
• Mentoring and team leadership
• Regulatory submission experience
• Problem-solving and analytical thinking
• Communication and presentation skills
• Cross-functional collaboration